Development and Validation of Morinaga Food Protein ELISA Kit: Experience in Japan

Yumiko Watanabe, Masahiro Shoji

Morinaga Institute of Biological Science Inc., 2-1-16, SACHIURA, KANAZAWA-KU, YOKOHAMA 236-0003 Japan

"Food allergies", that are known to cause life-threatening anaphylaxis from the intake of a minute amount of food allergen in allergic individuals, are a growing "Food safety" issue. With the aim of controlling food allergens in food, the development of the accurate methodology to detect food allergens is urgently required.

Currently, analytical methods basing on ELISA (Enzyme Linked Immuno-Sorbent Assay) are widely and routinely used for food allergen testing. However, it has become clear that ELISA fails to detect food allergen in certain processed food because of limitations in extraction efficiency of food allergens. In order to improve this, the unique extraction solution containing surfactant and reducing reagents was developed. The use of this extraction solution has enabled the detection of "hidden" allergen even in highly processed food, and allowed the provision of more precise safety information for allergenic individuals in Japan.

To address the need for the kit to be qualified for "Food safety", our ELISA kit was verified in terms of Specificity, Linearity, Repeatability, Reproducibility, Stability and so on. In addition to our in-house validation, inter-laboratory validation was also conducted under the direction of National Institute of Health Science, Japan.

Out of Egg, Milk, Wheat, Buckwheat, and Peanut kits, we will focus on the development and validation of the Morinaga Egg Protein kit in this presentation.